WORMCON: A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
Study Details
Study Description
Brief Summary
The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent parasites worldwide. The objective of this multicentre international study is to define the efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a standardised protocol. The trial will be undertaken among school age children in seven countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam - each with a different epidemiologic pattern of infection. A trial of this nature is urgently required because in spite of the wide usage of albendazole over the last 3 decades, there is still no key publication reporting the efficacy of the anthelmintic accurately, and to modern conventional standards, that can act as a central reference for the baseline efficacy. The latter is critically important because albendazole is now being used even more widely, as large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the intention of reducing morbidity in children. Such large scale usage of a drug risks resistance developing, but resistance cannot be detected unless benchmark values for baseline efficacy are widely known.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Albendazole Treatment with albendazole |
Drug: Albendazole
Treatment with albendazole
|
Outcome Measures
Primary Outcome Measures
- Efficacy of albendazole [14 to 30 days after treatment]
To determine the efficacy of albendazole, and this will be assessed by the reduction in parasite faecal egg counts between the pre- and post-intervention surveys. The latter will be conducted 14-30 days after treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Children should be infected with a minimum of 150 eggs/gram of any of the three species of STH (i.e. Ascaris or hookworms or Trichuris).
Exclusion Criteria:
-
Not willing to participate
-
Unable to give samples for follow up
-
Severe intercurrent medical condition
-
Diarrhoea at first sampling
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto René Rachou, Fundação Oswaldo Cruz | Minas Gerais | Brazil | ||
| 2 | Institut Pasteur in Cambodia, Clinical Pathology Unit | Phnom Penh | Cambodia | ||
| 3 | Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I | Yaounde | Cameroon | ||
| 4 | Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University | Jimma, | Ethiopia | ||
| 5 | Department of Gastrointestinal Sciences, Christian Medical College | Vellore | India | ||
| 6 | Public Health Laboratory | Zanzibar | Tanzania | ||
| 7 | National Institute for Malariology, Parasitology and Entomology | Hanoi | Vietnam |
Sponsors and Collaborators
- University Ghent
- World Health Organization
- George Washington University
- Commonwealth Scientific and Industrial Research Organisation, Division of Livestock Industries, Brisbane, Australia
- University of Nottingham
- Queensland Institute of Medical Research
Investigators
- Principal Investigator: Jozef Vercruysse, University Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2008/322